NHFOV Vs NIPPV Post-extubation in Preterm Neonates

NCT06620107 | Completed

• 1 other identifier: NHFOV vs NIPPV in neonates
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.

Conditions

Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• reintubation and the duration of respiratory support

  * The number of cases that required re-intubation and the time of failure of extubation in hours. * Duration of different types of respiratory support since birth till discharge from NICU.

  from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..

Secondary Outcomes (1)

• complications

  from the date of birth till the date of discharge from NICU or death (assessed up to 3 months).

Study Arms (2)

Noninvasive high frequency oscillation ventilation

ACTIVE COMPARATOR

preterm neonates with GA of 32 to 36 weeks ready for extubation

Device: noninvasive high frequency oscillation ventilation

Noninvasive intermittent positive pressure ventilation

ACTIVE COMPARATOR

preterm neonates with GA of 32 to 36 weeks ready for extubation

Device: noninvasive positive pressure ventilation

Interventions

noninvasive high frequency oscillation ventilation DEVICE

cases of group A extubated on NHFOV, and it will be provided by CNO, Medin device, Germany) via binasal prongs with the following parameters: * MAP of 6 cmH2O and will be titrated targeting a FiO2 ≤ 25-30%, maximum FiO2 will be 40% and target oxygen saturation will be 90-95%. * Frequency of 8 Hz and can be changed within the range of 8-12 Hz. * Amplitude of 7 cmH2O and can be titrated within the range of 7-10 cmH2O according to PaCO2.

Noninvasive high frequency oscillation ventilation

noninvasive positive pressure ventilation DEVICE

NIPPV will be provided by any type of neonatal ventilator available in the unit via binasal prongs starting with the following parameters: * Positive end expiratory pressure (PEEP) of 5 cmH2O and can be titrated to 8 cmH2O according to the oxygenation . * Peak inspiratory pressure (PIP) of 15 cmH2O and can be titrated to 25 cmH2O ,according to oxygenation , PaCO2 level and the chest expansion . * FiO2 ≤ 25-30% and can be increased to 40 % maximally targeting oxygen saturation of 90-95% . * Inspiratory time of 0.40-0.50 s . * Rate of 30 bpm and can be increased to maximum 50 bpm . * Synchronization will not be applied.

Noninvasive intermittent positive pressure ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
• When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
• Criteria for extubation:
• Blood gas analysis: PH \> 7.25 and PaCO2 ≤ 60 mmHg.
• Airway pressure (Paw) of 7 to 8 cmH2O.
• Required fraction of inspired oxygen (FiO2) ≤ 30%.
• Sufficient spontaneous breathing by clinical evaluation.

You may not qualify if:

• Full term neonates.
• Preterm neonates who will not require intubation.
• Preterm neonates with one of the following criteria:
• birth weight \> 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
• Cases that require reintubation after more than 72 hours of extubation.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafrelsheikh, Egypt

Location

Related Publications (1)

• Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.

  PMID: 32548084 BACKGROUND

Related Links

• Noninvasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with moderate-severe respiratory distress syndrome: A preliminary report

Study Officials

• Heba SM El-Mahdy

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric demonstrator at faculty of medicine- kafrelsheikh university

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: January 20, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)